We cover one device warning letter and review a mislabeling of PURELL Hand Sanitizer.
FDA-regulated firms face an enormous challenge keeping up with agency priorities and expectations—especially companies that produce older products within an ever-changing regulatory landscape. While firms continue to manufacture these older products to serve their customers and protect their brand, there are many potential quality compliance issues that can arise.
The FDA 510(k) Program, also referred to as premarket notification, is an FDA marketing clearance application and is the most common avenue of premarket submission for medical devices. This article serves to provide you with a high-level understanding of the items required in 510(k) submissions and resources to help you during the process.
How to Talk So That FDA Will Listen, and How to Listen When They Talk: Advice That Could Be Worth Millions
Former FDA Team Leader and Pearl Pathways Senior Regulatory Advisor Dr. Robert Seevers shares his experience reviewing and submitting NDAs.
FDA published five GMP drug warning letters and one to a device maker. FDA frequently requests “independent” assessments indicating that they do not think the firms are capable of performing these activities internally.
Enforcement includes one untitled letter and one warning letter to cell therapy companies. Also, FDA posted and then removed one warning letter to a device manufacturer.
How Key Pharma and Device Executives Are Developing the Next Generation of Quality Professionals and Leaders
A team comprising over a dozen chief quality officers (CQOs) representing the medical device, pharmaceutical, animal health, and consumer healthcare industries has pooled its collective passion and wisdom – with input from FDA and other drug and device regulatory agencies – to establish and implement an innovative education curriculum that will help develop the next generation of scientists entering the industry.
Another busy week on the warning letter enforcement front. We address one warning letter to a device firm, one to a fertility clinic with similar issues to one posted last week, and four to drug firms. This includes the warning letters to Glenmark and Torrent located in India, both of which were announced last week but not yet posted by FDA.
GMP expert Jerry Chapman covers the presentation by FDA Office of Combination Products (OCP) Associate Director for Policy John Barlow Weiner in which he reviews PMSR guidance and implementation, the RFD process, and new guidance in progress.